MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD; PTA BALLOON DILATATION CATHETER

Catalog Number	ATG80164
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: d2b (lit; dqy).H11: section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas gold pta balloon catheter.During the procedure, the balloon was allegedly caught in the sheath during extraction.It was further reported that the balloon part fell out of the cate when it was pulled and it got caught on the sheath and the balloon part broke off.Reportedly, the entire sheath was pulled out and the balloon was successfully removed without remaining in the body.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was returned for evaluation.Upon visual inspection, the balloon catheter was received in two segments and along with an unknown brand sheath.Segment 1 consist of the balloon detached at the proximal end.The inner guidewire lumen portion was present within the balloon as well.Segment 2 consist of remaining catheter and y-hub.The inner gw was extending out from the outer catheter.The outer catheter was noted to be stretched.Due to the condition of the returned device such as detachment, functional testing for difficult to remove is not possible.Therefore, the investigation is confirmed for the reported detachment and removal difficulty as the device was received with complete detachment of balloon and shaft, which could have caused difficulty in removing through sheath.A definitive root cause for the reported detachment and removal difficulty could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D2b (lit; dqy), g3, h6 (component, method, result, conclusion) section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas gold pta balloon catheter.During the procedure, the balloon was allegedly caught in the sheath during extraction.It was further reported that the balloon part fell out of the cate when it was pulled and it got caught on the sheath and the balloon part broke off.Reportedly, the entire sheath was pulled out and the balloon was successfully removed without remaining in the body.There was no reported patient injury.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21959207
• Report Number: 2020394-2025-00660
• Device Sequence Number: 20639982
• Product Code: DQY
• UDI-Device Identifier: 00801741060816
• UDI-Public: (01)00801741060816(17)270918(10)93WJ0048
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ATG80164
• Device Lot Number: 93WJ0048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown